Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors (NCT06714617) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors
United States120 participantsStarted 2025-04-10
Plain-language summary
The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed the informed consent form
✓. Age ≥18 years.
✓. Weighs more than 40 kg. For doses \<0.3 mg/kg, subject must weigh ≥70 kg.
✓. Has a life expectancy of ≥3 months.
✓. Has documented locally advanced or metastatic HER2-positive solid tumor(s) (IHC 1+ to 3+ or in situ hybridization \[ISH\] positive) or HER2-mutant tumor specimen not amenable to curative surgery or radiation and has received at least 1 line of standard therapy in the advanced/metastatic setting, or for which no standard treatment is available, including:
✓. Cohort 1: HER2-positive breast cancer (BC);
✓. Cohort 2: HER2-positive gastric/gastroesophageal junction cancer (GC/GEJ);
✓. Cohort 3: HER2-positive or HER2-mutant non-small cell lung cancer (NSCLC);
Exclusion criteria
✕. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration.
✕. Concomitant use of strong inhibitors and inducers of any CYP3A4 enzyme or P-gp transporter system within 2 weeks or 5 half-lives (whichever is longer) prior to the first administration and throughout all parts of the study.
What they're measuring
1
Participants with Dose-limiting toxicities
Timeframe: 1 Year
2
Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs)
Timeframe: 1 Year
3
To determine the MTD if reached or MAD and two or more RDEs of BL-M17D1
✕. History of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure at any time, or history of myocardial infarction or unstable angina pectoris within 6 months before enrollment.
✕. Prolonged QT interval (QTcF \>470 msec), complete left bundle branch block, Grade 3 atrioventricular block, or a history of additional risk factors for torsades de pointes (TdP; eg, heart failure as defined in Exclusion Criterion 3, chronic or recurrent hypokalemia that requires medical intervention, congenital long QT syndrome, family history of long QT syndrome) or any current concomitant medication known to prolong the QT/QTc interval or cause TdP.
✕. Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for type 1 diabetes, hypothyroidism that can be controlled by standard of care treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis).
✕. Other prior malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years prior to screening.
✕. Poorly controlled hypertension by two types of antihypertensive drugs (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg).
✕. Advanced or clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease and asthma, restrictive lung disease, pulmonary hypertension etc.